The present invention relates to a system and method for aerosol delivery of a drug. More particularly the present invention relates to a disposable cassette containing a single pre-measured dose of the drug supplied within at least one breakable container and to methods of use thereof.
Medical disorders of the upper airway are common. Asthma affects approximately 10% of the adult population. Asthmatic patients, together with those suffering from cystic fibrosis, bronchitis, smoking related disorders and infants with difficulty maintaining adequate oral ventilation are probably found in 20-50% of households. Patients with these disorders are generally treated with drugs delivered as an aerosol suspension.
Aerosol delivery of drugs to the airway is typically accomplished by either a stream of air created by a motorized pump, or by use of a pressurized propellant gas (e.g. aerosol canister).
Aerosol delivery devices which include a motorized pump typically require measuring and mixing of components of the aerosol. This provides an opportunity for error during measurement or mixing and may lead to delivery of an incorrect dose of medication. This problem is common to both hospitals and home treatment. In a hospital, a single staff member may treat many patients with different doses of the same drug in the course of a workday. At home a patient, for example one suffering an asthma attack, may be under stress when measuring and mixing components of a mixture.
Devices which rely upon a pressurized propellant gas are typically capable of delivering a pre-measured dose of medication with each actuation (e.g. metered dose inhalers). However, medication packaged in this way is relatively expensive. In addition, patients with poor coordination (e.g. young children, geriatric patients) often have difficulty using these devices. Thus, a device which delivers medicine slowly over the course of a longer period of time is often required.
There is thus a widely recognized need for, and it would be highly advantageous to have, a system and method for aerosol delivery of a drug devoid of the above limitations.
According to one aspect of the present invention there is provided a dual-purpose medical device for upper airway treatment, the device comprising: (a) a disposable cassette having a first opening, a second opening and an interior volume, the cassette being connectable to an airflow generator by means of the first opening; (b) the airflow generator capable of creating a flow of air through the disposable cassette such that: aerosol delivery of a drug residing in the internal volume of the cassette may be accomplished.
According to another aspect of the present invention there is provided a method for aerosol delivery of a drug, the method comprising the steps of: (a) connecting an airflow generator to a disposable cassette via a first opening of the cassette, the cassette comprising the first opening, a second opening and an interior volume; and (b) causing air to flow into the internal volume of the cassette via the first opening and outward from the internal volume via the second opening towards an airway of a patient such that the aerosol delivery of a drug residing in the internal volume of the cassette is accomplished.
According to further features in preferred embodiments of the invention described below, the device further comprises (c) a re-usable holder for the cassette.
According to still further features in the described preferred embodiments the cassette further comprises: (i) at least one partition dividing the interior volume into at least two chambers; and (ii) an openable region in each of the at least one partition.
According to still further features in the described preferred embodiments the device further comprises a mechanism for opening the openable region.
According to still further features in the described preferred embodiments the method comprises the additional step of: (c) placing the cassette within a re-usable holder.
According to still further features in the described preferred embodiments the method comprises the additional step of (c) providing within the cassette: (i) at least one partition dividing the interior volume into at least two chambers; and (ii) an openable region in each of the at least one partition wherein at least one of the chambers contains at least one component of the drug.
According to still further features in the described preferred embodiments the method comprises the additional step of providing perforations surrounding a portion of the openable region in each of the at least one partition such that opening thereof is facilitated by the perforations.
According to still further features in the described preferred embodiments the method comprises the additional step of opening the openable region by means of mechanism for opening the openable region.
According to still further features in the described preferred embodiments the method comprises the additional step of aerosolizing the drug to form a plurality of micro-droplets by means of an aerosol jet connected to the second opening of the cassette.
According to one aspect of the present invention there is provided a system for aerosol delivery of a drug. The system includes: (a) a disposable cassette containing a single pre-measured dose of the drug within an interior volume of the cassette, the cassette including a first opening, a second opening and the interior volume and being connectable to an airflow generator by means of the first opening; (b) the single pre-measured dose of the drug supplied within at least one breakable container, the at least one breakable container occupying at least a portion of the interior volume of the cassette; (c) a drug release mechanism, the drug release mechanism designed and constructed to break the at least one breakable container and release the single pre-measured dose of the drug. Air from the airflow generator is capable of generating a flow of air into the interior volume of the cassette via the first opening and outward from the interior volume via the second opening towards an airway of a patient such that aerosol delivery of a drug residing in the interior volume of the cassette may be accomplished.
According to another aspect of the present invention there is provided a method of aerosol delivery of a drug, the method includes: (a) supplying a disposable cassette containing a single pre-measured dose of the drug within an interior volume of the cassette, the cassette including a first opening, a second opening and the interior volume and being connectable to an airflow generator by means of the first opening; (b) operating a drug release mechanism designed and constructed to break the at least one breakable container and release the single pre-measured dose of the drug into the interior volume of the cassette; (c) generating a flow of air into the interior volume of the disposable cassette via a first opening thereof and outward from the interior volume via a second opening thereof towards an airway of a patient such that aerosol delivery of the single pre-measured dose of the drug is accomplished. The single pre-measured dose of the drug is contained within at least one breakable container, the at least one breakable container occupying at least a portion of the interior volume of the cassette
According to yet another aspect of the present invention there is provided a method of aerosol delivery of a drug. The method includes: (a) supplying at least two breakable packets, each of the packets containing a portion of a single pre-measured dose of the drug, the packets residing within at least a portion of an interior volume of a disposable cassette; (b) opening the packets within the interior volume of the disposable cassette thereby preparing the single pre-measured dose of the drug; and (c) generating a flow of air into the interior volume of the disposable cassette via a first opening thereof and outward from the interior volume via a second opening thereof towards an airway of a patient such that aerosol delivery of the single pre-measured dose of the drug is accomplished. xe2x80x9cPreparationxe2x80x9d as used herein may refer for example to mixing components of the drug to form an active ingredient or appropriate dilution.
According to further features in preferred embodiments of the invention described below, the further includes a re-usable holder designed and constructed to reversibly engage at least a portion of the cassette. The holder is designed and constructed to facilitate attachment of the cassette to the airflow generator.
According to still further features in the described preferred embodiments the at least one breakable container includes at least two breakable containers.
According to still further features in the described preferred embodiments engagement of the re-usable holder to the cassette serves to operate the drug release mechanism.
According to still further features in the described preferred embodiments the drug release mechanism includes a piston designed and constructed to be linearly displaced along an axis of the interior volume, thereby breaking the at least one breakable container.
According to still further features in the described preferred embodiments the cassette further includes a third opening to facilitate insertion of the piston into the interior volume of the cassette.
According to still further features in the described preferred embodiments the piston further includes at least one protuberance designed and constructed to break the breakable container as the piston is linearly displaced.
According to still further features in the described preferred embodiments at least one opening selected from the group consisting of the first opening and the second opening is located on the piston.
According to still further features in the described preferred embodiments the system further includes an aerosol jet connectable to the second opening of the cassette and capable of delivering the drug as a plurality of micro-droplets.
According to still further features in the described preferred embodiments the method further includes reversibly engaging at least a portion of the disposable cassette by means of a re-usable holder, the holder designed and constructed to facilitate attachment of the cassette to the airflow generator.
According to still further features in the described preferred embodiments the single pre-measured dose of the drug is contained within at least two breakable containers.
According to still further features in the described preferred embodiments the reversibly engaging the re-usable holder to the cassette serves to operate the drug release mechanism.
According to still further features in the described preferred embodiments operating the drug release mechanism includes linearly displacing a piston along an axis of the interior volume, thereby breaking the at least one breakable container.
According to still further features in the described preferred embodiments the method further includes providing an aerosol jet connectable to the second opening of the cassette and capable of delivering the drug as a plurality of micro-droplets.
According to still further features in the described preferred embodiments the method further includes providing a third opening, in the cassette to facilitate insertion of the piston into the interior volume thereof.
The present invention successfully addresses the shortcomings of the presently known configurations by providing a system and method for aerosol delivery of a drug which relies upon a single pre-measured dose of the drug.